MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics

Does anybody know where I could find MHLW MO169, the 2021 revision. All I can find is the correspondence table and the Ch.3 translation. Thanks!

According to the information available @ Revision of Japanese Medical Device QMS requirements | Pharmaceuticals and Medical Devices Agency the 2021 revision affects only Chapter 2. As far as I can see, the revision is available @ https://www.pmda.go.jp/files/000239873.pdf


Good luck.

Kate Gavin said:

Does anybody know where I could find MHLW MO169, the 2021 revision. All I can find is the correspondence table and the Ch.3 translation. Thanks!

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Hi Kate Gavin, were you able to find the translated version of Chapter 2 of 2021?

Hi all,

I'm bumping this thread. Does anyone have a copy of the complete 2021 version of MHLW MO169 translated in English? Or a copy of the 2014 version? While it seems that the revisions between these two focus on the second chapter, some of the details at the Revision of Japanese Medical Device QMS requirements | Pharmaceuticals and Medical Devices Agency webpage that Sidney had linked above indicate that there are revisions to other chapters as well.

Thanks!

Hi All,
I'm bumping this as well - is it possible to get a complete copy of the most recent version of MHLW MO 169?
Also, is anyone aware of any English language training for the regulation?